NCT05721430

Brief Summary

The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the "quality of life" outcomes for Pakistan and Urdu speaking people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2023

Last Update Submit

August 8, 2023

Conditions

Infant Development

Keywords

Health related quality of life of Infants

Outcome Measures

Primary Outcomes (1)

  • Quality of Life of Infants age 1 to 12 months

    Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 months

    6 months

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The sample size was 43. Sample size was calculated by raosoft online software. Margin of error 5% Confidence level 95% Population size 20000 Response distribution 50% Sample Selection Criteria

You may qualify if:

  • Parents of both genders included
  • Parents of infant age 1 to 12 months were included.

You may not qualify if:

  • Parents suffering from psychological disorders
  • Parents with severe behavior issue
  • Parents who cannot understand Urdu

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riphah international university

Lahore, Punjab Province, Pakistan

Location

Rising Sun Institute

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.

    PMID: 20730626BACKGROUND

Study Officials

  • Saiqa Tabassum, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 10, 2023

Study Start

February 15, 2023

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

PA(2)